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On this page you will find order codes, technical specifications and documents for the selected product.
|Product name||Catalog no.||Technology||Packaging|
|GeneProof Factor V Leiden MC PCR Kit||FV/MC/200||PCR||for 180 tests|
|Indication||in vitro diagnostic medical device|
|Regulatory Status||CE IVD / EC Directive 98/79/EC|
|Intended User||For professional use in laboratories with trained staff|
|Test Principle||Real-time polymerase chain reaction (PCR)|
|Type of Analysis||Qualitative|
|Automated / Manual detection||Automated|
|Target||G1691A Polymorphism in the F5 gene of Factor V Leiden (rs6025)|
|Specificity||Single nucleotide guanine/adenine polymorphism in the F5 gene of Factor V Leiden in site 1691 (rs6025)|
|Concentration Range||10-90 ng/µl|
|Negative Percentage Agreement||100% (CI95%: 97.04% - 100%)|
|Positive Percentage Agreement||100% (CI95%: 79.08% - 100%)|
|Overall Percentage Agreement||100% (CI95%: 97.35% - 100%)|
|Validated Specimen||Whole blood|
|Validated Extraction Methods||myCROBE/croBEE 2.0 Universal Extraction Kit|
myCROBE® Fully Automated Instrument
|Detection Channels||FAM, HEX|
|External Quality Assessment||Regularly tested in INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com|